EP2016963A1

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Info

Publication number: EP2016963A1
Application number: EP07013976A
Authority: EP
Inventors: Rishi Baid
Original assignee: Poly Medicure Ltd
Current assignee: Poly Medicure Ltd
Priority date: 2007-07-17
Filing date: 2007-07-17
Publication date: 2009-01-21
Anticipated expiration: 2027-07-17
Also published as: ES2351233T5; ES2391445T3; EP2241346A3; KR20100059803A; CN102488946B; TN2010000031A1; ES2351233T3; MY152198A; EA201070156A1; US20100222749A1; JP5161308B2; JP2010533533A; CN101743028A; EP2241346A2; AR067547A1; BRPI0814728B1; WO2009010847A3; JP5666532B2; KR101554279B1; UA93969C2

Abstract

The application relates to a needle safety device (28) for a medical device, the needle safety device comprising: a base portion (30) having a bore extending in an axial direction therethrough for receiving a needle (24); two opposing jaws (34,36) extending from the base portion (30) generally in the axial direction and each having a head portion (38,40) in the region of its free end, wherein at least one of the head portions (38,40) forms a locking shoulder (50) for securing the needle safety device (28) in a housing of the medical device; and an elastic element (44) surrounding the jaws (34,36) in a region between the base portion (30) and the head portions (38,40), wherein the elastic element (44) and the jaws (34,36) are configured such that the jaws (34,36) can be spread apart against a restoring force of the elastic element (44) in order to allow the needle (24) received in the bore to extend all the way through the needle safety device (28). The application also relates to a needle (24) for a medical device and to an intravenous catheter apparatus comprising a needle (24) and a needle safety device (28).

Description

The present invention relates to a needle safety device for a medical device such as, for example, an intravenous catheter apparatus, which comprises a base portion having a bore extending in an axial direction therethrough for receiving a needle, and two opposing jaws extending from the base portion generally in the axial direction and each having a head portion in the region of its free end, wherein at least one of the head portions forms a locking shoulder for securing the needle safety device in a housing of the medical device.
A needle safety device of this kind is generally known and operative as a guard for the tip of a needle of the medical device by automatically covering the needle tip during withdrawal of the needle from a patient. The needle safety device thereby serves to prevent accidental pricking of, for example, a medical professional by the needle after removal of the needle from the medical device.
It is an object of the invention to provide a needle safety device which provides a better protection against accidental pricking by the needle.
This object is satisfied by a needle safety device having the features of claim 1.
The needle safety device of the invention is characterized by an elastic element at least partly surrounding the jaws in a region between the base portion and the head portions, wherein the elastic element and the jaws are configured such that the jaws can be spread apart against a restoring force of the elastic element in order to allow the needle received in the bore to extend all the way through the needle safety device.
Due to the elastic element exerting its restoring force on the jaws in the spread apart state of the jaws, which is the state in which the medical device, for example, an intravenous catheter apparatus, is typically shelved prior to use, the elastic element ensures that the spread apart jaws will snap together and guard the needle tip upon withdrawal of the needle from the medical device even after a longer shelf time, thereby continuously ensuring a correct functioning of the needle safety device. In addition, the elastic element prevents the jaws from becoming loose when the needle safety device slides along the needle, thereby further aiding a correct functioning of the needle safety device.
As a result of the elastic element being arranged in a region between the base portion and the head portions of the jaws, the elastic element also helps prevent the needle tip from protruding sideways out of the needle safety device, thereby further increasing the protecting function of the needle safety device.
Furthermore, due to the arrangement of the elastic element between the base portion and the head portions of the jaws, a locking recess for receiving a locking protrusion formed inside the housing of the medical device is formed between the elastic element and the locking shoulder of the at least one head portion. When the locking protrusion engages with the recess formed by the shoulder of the at least one head portion and the elastic element, the needle safety device is safely secured inside the housing of the medical device and is, in particular, prevented from movement in the axial direction relative to the housing.
The elastic element may comprise a tension ring completely surrounding the jaws, and/or a clamp, bracket, "C" clip or the like surrounding the jaws only in part.
According to a preferred embodiment, as seen in the axial direction, the elastic element covers a substantial part of the jaws. The elastic element forms a partial sidewall and together with the jaws defines a chamber inside the needle safety device, in which the needle tip is held after complete withdrawal of the needle from the medical device, thereby further increasing the guarding function of the needle safety device.
The axial dimension of the elastic element may range from about one fifth of the length of the jaws to about two thirds or three fourths of the length of the jaws, and preferably is in the range of about one third of the length of the jaws.
Preferably, the elastic element is made from a material having elastic properties, for example, an elastic material such as rubber, silicone or the like. Due to its elastic properties, the elastic element creates a restoring force on the jaws, when the needle fully extends through the needle safety device thereby spreading the jaws apart and expanding the elastic element. As soon as the needle tip passes the free ends of the jaws upon pulling the needle through the needle safety device, the jaws are positively collapsed by the elastic element due to its restoring force.
In accordance with a further embodiment, the jaws are connected to each other by at least one link in a region between the base portion and the head portions. Preferably, the link is arranged in the region of the elastic element. The link may be provided on only one side of the jaws. Alternatively, first and second links may be provided on opposite sides of the jaws.
Preferably, the at least one link is formed to have spring-like properties such that the jaws can be spread apart against a restoring force of the link. For example, the link may have a curved shape, such as an S- or Z-like shape. Alternatively, the link may have a substantially straight shape.
The at least one link prevents the two jaws from spreading apart two far, thus preventing over-stretching of the elastic element which could result in a loss of elastic properties. Furthermore, the link supports the elastic element in exerting a force on the jaws in the collapsing direction, thereby aiding the elastic element in preventing the jaws from becoming loose when the needle safety device slides along the needle. In addition, the link causes the jaws to collapse even if the elastic element should fail in its function. The link is designed such that it retains its spring-like properties over the period of shelf live.
To allow for a simplified and cost-effective production of the needle safety device, the base portion, the jaws, and preferably also the at least one link may be integrally formed and preferably made from a plastic material, for example, by injection molding. Alternatively, the base portion, the jaws, and preferably also the at least one link may be made from a metal material. According to a further embodiment, the base portion, the jaws and/or the link each comprise a different material or combination of materials, such as a different plastic material, a different metal material or a different combination of plastic and/or metal materials. For example, the base may be made from a metal material and the jaws may be made from a plastic material, or vice versa. It is also considered that the inner part of the jaws, which contacts the needle, is made from a thermoplastic material such as TPE, whereas the outer part of the jaws may be made from a different material, for example, a plastic, metal, composite or elastomer material, so that the needle safety device causes less friction when sliding along the needle thereby facilitating the withdrawal of the needle.
In order to prevent the needle tip guarded by the needle safety device from protruding beyond the free ends of the jaws, at least one of the jaws has an angled end section at its free end, which extends towards the other one of the jaws in a direction generally perpendicular to the axial direction.
Preferably, the length of the at least one angled end section is selected such that the angled end section is supported on the needle when the needle extends all the way through the needle safety device, thereby spreading the jaws apart far enough for the shoulder of the head portion of the jaw having the angled end section to be able to engage behind the locking protrusion provided in the housing of the medical device.
Further subject matter of the invention is a needle for a medical device such as, for example, an intravenous catheter apparatus, which has an inner profile, i.e. cross-section area defined by the inner periphery or circumference of the needle, a principal outer profile, i.e. principal cross-section area defined by the outer periphery or circumference of the needle, and a needle tip, the needle further comprising at least one enlargement in the region of the needle tip, wherein the enlargement is formed from an increase of the outer profile, whereas the inner profile remains substantially unchanged.
Still further subject matter of the invention is a medical device, in particular an intravenous catheter apparatus, comprising a needle of the aforementioned type and a needle safety device, in particular of the above described kind, which is slidably arranged on the needle for protecting the needle tip, wherein the needle safety device includes a base portion having a bore extending therethrough for receiving the needle, the bore being adapted to the principal outer profile of the needle.
The enlargement and thus increase in effective diameter in the region of the needle tip prevents the needle tip from being pulled through the base portion of the needle safety device during withdrawal of the needle from the medical device. In other words the enlargement prevents the needle safety device from sliding beyond the needle tip and thus ensures that the needle tip is continuously and reliably guarded by the needle safety device after removal of the needle from the medical device.
By forming the enlargement such that only the outer profile of the needle is increased, whereas the inner profile remains unchanged, in other words by maintaining a substantially constant inner cross-section area throughout the entire length of the needle, blood from a patient entering the needle can freely flow along the inside of the needle. In other words a flashback of blood, which occurs when the needle penetrates a vein, is not adversely affected by the enlargement.
The enlargement may be formed by subjecting the needle to concentrated heat at a localized area using, for example, a welding process such as a laser welding process, with or without addition of additional material.
Alternatively, the enlargement may be formed from additional material dispensed onto the outer surface of the needle. In order to locate the dispensed material in a defined position, a recess or groove may be formed in the outer surface or circumference of the needle.
The additional material may, for example, be selected from at least one of a plastic material, an adhesive, a resin and a metal material.
In the case of the additional material being a metal material, the enlargement may, for example, be formed by build-up welding of the additional material onto the needle.
Preferred embodiments of the invention are described in the following description and in the accompanying drawings, wherein:

Fig. 1: shows a view partly in cross-section of a wing housing of an intravenous catheter apparatus, including a nee- dle safety device of the invention inserted therein and a needle extending therethrough;
Fig. 2: shows a view partly in cross-section of the wing hous- ing ofFig. 1, including the needle safety device, but not the needle;
Fig. 3A: shows a side view of the needle safety device ofFig. 1 including a tension ring, with the needle safety device guarding the tip of the needle;
Fig. 3B: shows a side view of the needle safety device ofFig. 3A without the needle or the tension ring;
Fig. 3C: shows a depression for receiving a tension ring, which is formed in the outer surface of a needle safety device according to an alternative embodiment of the inven- tion;
Fig. 4A: shows a side view of an alternative embodiment of the needle safety device of the invention, including a ten- sion ring;
Fig. 4B: shows a side view of the needle safety device ofFig. 4A without the tension ring;
Fig. 5: shows a plan view of the wing housing ofFig. 1;
Fig. 6A: shows a cross-sectional view of a section of the wing housing ofFig. 5 detailing an annular locking protru- sion;
Fig. 6B: shows a cross-sectional view of a section of the wing housing ofFig. 5 detailing an alternative embodiment of the annular locking protrusion;
Fig. 7A: shows a side view of the needle tip region of the needle ofFig. 1 showing the details of an enlargement formed on the outer surface of the needle;
Fig. 7B: shows a plan view of the needle tip region ofFig. 7A;
Fig. 8: shows a cross-sectional view of the needle ofFig. 7 in the region of the enlargement which has been formed by welding; and
Fig. 9: shows cross-sectional views of the needle ofFig. 7 in the region of the enlargement, illustrating the forma- tion of the enlargement by a deposition process.

Referring toFig. 1, a catheter hub orwing housing 10 of an intravenous catheter apparatus is shown. Thewing housing 10 comprises amain body 12 of generally tubular form and extending in an axial direction. The main body has adistal end 14 and aproximal end 16. A catheter 17 (Fig. 5) is attached to themain body 12 at thedistal end 14 of themain body 12. Aport 18 extends from themain body 12 in a direction generally perpendicular to the axial direction. Wings 20 (Fig. 5) are provided at themain body 12 opposite from theport 18. Themain body 12 defines achamber 22 extending from theproximal end 16 towards thedistal end 14.
Prior to use of the intravenous catheter apparatus, aneedle 24 extends through thewing housing 10 in the axial direction. Theneedle 24 has an inner profile, i.e. cross-section area defined by the inner periphery or circumference of theneedle 24, which is substantially constant across the length of theneedle 24. A principal outer profile, i.e. principal cross-section area defined by the outer periphery or circumference of theneedle 24, is also substantially constant across the length of theneedle 24 except for anenlargement 26 of theneedle 24 provided in the region of the needle tip at the distal end of theneedle 24, which will be described in more detail below with reference toFigs. 7 to 9.
Still referring toFig. 1, aneedle safety device 28 is slideably arranged on theneedle 24. Prior to use of the intravenous catheter apparatus, theneedle safety device 28 is inserted into thechamber 22 from theproximal end 16 of themain body 12.
As can be seen fromFigs. 1,3 and4, theneedle safety device 28 comprises abase portion 30 which has a bore extending in the axial direction therethrough for receiving theneedle 24. The bore is matched in shape and size to the principal outer profile of theneedle 24.
First andsecond jaws 34, 36 extend from thebase portion 30 generally in the axial direction. Thefirst jaw 34 has afirst head portion 38 in the region of its free end, and thesecond jaw 36 has asecond head portion 40 in the region of its free end. Thefirst head portion 38 extends beyond thesecond head portion 40 and has anangled end section 42 at its free end, which extends towards thesecond jaw 36 in a direction generally perpendicular to the axial direction.
The length of theangled end section 42 is selected such that theangled end section 42 protrudes over at least a part of thesecond head portion 40, when thejaws 34, 36 are in a relaxed position as is shown inFigs. 2,3 and4. When theneedle 24 extends all the way through theneedle safety device 28, such as prior to use of the intravenous catheter device as shown inFig. 1, theangled end section 42 is supported on theneedle 24, whereby thefirst jaw 34 is forced away from thesecond jaw 36 from its relaxed position into a spread apart position.
Thejaws 34, 36 are surrounded by atension ring 44 in a region between thebase portion 30 and thehead portions 38, 40. Thetension ring 44 is made from an elastic material, such as rubber, silicone or the like. Thetension ring 44 is fitted around thejaws 34, 36 such that it exerts a restoring force on thejaws 34, 36, when the jaws are spread apart by theneedle 24, as shown inFig. 1.
As is illustrated inFigs. 1,2,3A and4A, thetension ring 44 covers a substantial part of thejaws 34, 36 seen in the axial direction. Specifically, the axial dimension of the tension ring may range from about one fifth of the length of the jaws to about two thirds or three fourth of the length of the jaws, and preferably is in the range of about one third of the length of the jaws.
Referring toFigs. 3B and4B, thejaws 34, 36 are connected to each other by alink 46. Thelink 46 is arranged approximately half way along the length of thejaws 34, 36 between thebase portion 30 and thehead portions 38, 40, i.e. in the region of thetension ring 44. More specifically, thelink 46 is covered by thetension ring 44, as is illustrated inFigs. 3A and4A.
In the embodiments shown, thelink 46 is provided on only one side of thejaws 34, 36. However, it is generally possible to provide a link on both sides of thejaws 34, 36. Furthermore, it is generally possible to provide more than one link on one side of thejaws 34, 36 or on both sides of thejaws 34, 36.
Thelink 46 shown inFigs. 3B and4B has a curved shape and, in particular, an S-like shape providing thelink 46 with spring-like properties. Thereby thelink 46 also exerts a restoring force on thejaws 34, 36, when thejaws 34, 36 are spread apart by theneedle 24, as shown inFig. 1. Thelink 46 thus aids thetension ring 44 in biasing thejaws 34, 36 towards each other.
It is to be appreciated that thelink 46 does not necessarily need to have an S-like shape, but it may also have a Z-like shape or any other shape which is suitable to provide thelink 46 with spring-like properties.
Thebase portion 30, thejaws 34, 36 and thelink 46 are integrally formed from a plastic material, for example, by injection moulding. Alternatively, thebase portion 30, thejaws 34, 36 and thelink 46 may be made from a metal material.
As can be seen fromFigs. 3B and4B, thejaws 34, 36 are slightly angled towards each other in the region of thetension ring 44, resulting in the outer profile of theneedle safety device 28 being tapered towards thehead portions 38, 40.
In order to hold thetension ring 44 in a fixed position on thejaws 34, 36, two partannular protrusions 48 are formed on the outer surface of thejaws 34, 36, as shown inFigs. 1,2 and3. The partannular protrusions 48 are spaced apart a distance matched to the axial dimension of thetension ring 44. The partannular protrusions 48 can thus receive thetension ring 44 between themselves, thereby functioning as guides for thetension ring 44 and securing the position of thetension ring 44 on thejaws 34, 36. In addition to or instead of the partannular protrusions 48, a depression orgroove 49 may be formed in the outer surface of thejaws 34, 36, as shown inFig. 3C.
It is to be noted that the partannular protrusions 48 and depression orgroove 49 are optional, i.e. theneedle safety device 28 can also be made without any part annular protrusions, depression or groove, as shown inFigs. 4A and 4B.
As can be seen fromFigs. 3 and4, a lockingshoulder 50 is formed at the side of eachhead portion 38, 40 facing thetension ring 44. The lockingshoulder 50 and thetension ring 44 together form a recess orgroove 52.
Referring again toFig. 1, anannular locking protrusion 54 is formed on the inner surface of themain body 12 of thewing housing 10 and protrudes into thechamber 22.
Prior to use of the intravenous catheter apparatus, i.e. when theneedle safety device 28 is inserted into thechamber 22 and theneedle 24 extends all the way through theneedle safety device 28 and thewing housing 10, theannular locking protrusion 54 is received in therecess 52 defined by thetension ring 44 and thehead portion 38 of thefirst jaw 34, which is forced away from thesecond jaw 36 due to theangled end section 42 supported on theneedle 24.
Because of theannular locking protrusion 54 engaging into therecess 52 of theneedle safety device 28 in the spread apart state of thejaws 34, 36, theneedle safety device 28 is secured against movement relative to themain body 12 in the axial direction. Specifically, theneedle safety device 28 cannot be pulled out of thewing housing 10, since the lockingshoulder 50 of thehead portion 38 of thefirst jaw 34 engages behind theannular locking protrusion 54.
As is illustrated inFig. 5, theannular locking protrusion 54 is a distance away from theproximal end 16 of themain body 12, this distance being in the range of 5 mm to 6 mm or more.
Theannular locking protrusion 54 may have a substantially rectangular profile with rounded edges (Fig. 6A), a rounded profile similar to a Gaussian curve or a semi-sinusoidal curve (Fig. 6B), or any other profile suitable for locking of theneedle safety device 28 in thewing housing 10.
Preferably, the lockingprotrusion 54 is of continuous annular shape. However, it is generally also possible to consider anannular locking protrusion 54 having one or more interruptions.
When theneedle 24 is being withdrawn from a patient and, thus, from the intravenous catheter apparatus, theneedle 24 is simultaneously pulled through theneedle safety device 28. As has been mentioned above, as long as thejaws 34, 36 are in their spread apart position, theneedle safety device 28 is secured against axial movement relative to themain body 12, i.e. theneedle safety device 28 remains in thewing housing 10.
However, as soon as thetip 56 of theneedle 24 moves into theneedle safety device 28, i.e. passes beyond theangled end section 42 of thefirst jaw 34, thefirst jaw 34 snaps back or collapses into its relaxed position, as shown inFig. 3, due to the restoring force exerted by thetension ring 44 and thelink 46.
When thefirst jaw 34 adopts its relaxed position, the lockingprotrusion 54 is released from therecess 52 and the lockingshoulder 50 of thefirst head portion 38 is disengaged from the lockingprotrusion 54. As a result, thesafety device 28 is free to move relative to themain body 12 in the axial direction. Specifically, theneedle safety device 28 can now be pulled out of thewing housing 10, as is indicated inFig. 2.
As is illustrated inFigs. 3A and7, the position of theenlargement 26 formed on the outer surface of theneedle 24 is selected such that theenlargement 26 abuts thebase portion 30 of theneedle safety device 28 as soon as theneedle tip 56 has passed the free end of thesecond jaw 36.
Since the maximum outer dimension of theneedle 24 in the region of theenlargement 26 is larger than the dimension of the bore in thebase portion 30, which is adapted to the principal outer profile or circumference of theneedle 24, theneedle 24 can not be further pulled out of theneedle safety device 28 than is shown inFig. 3. In other words, because of theenlargement 26, theneedle safety device 28 cannot slide off theneedle 24 during normal use of theneedle 24 andneedle safety device 28, i.e. unless an excessive external force is applied to theneedle 24 and/or theneedle safety device 28.
With theneedle tip 56 captured inside theneedle safety device 28, theneedle tip 56 is covered by theangled end section 42 of thefirst jaw 34. At the same time, thetension ring 44 prevents theneedle tip 56 from coming sideways out of theneedle safety device 28. Hence, theneedle tip 56 is safely guarded by theneedle safety device 28.
Referring toFigs. 8 and 9, theenlargement 26 of theneedle 24 is formed such that the inner profile of theneedle 24 is not affected by the formation of theenlargement 26, i.e. remains substantially unchanged. Thereby, when theneedle 24 penetrates a vein, the flow of blood through theneedle 24 will not be adversely affected by theenlargement 26.
Theenlargement 26 may be formed as a bump by subjecting theneedle 24 to concentrated heat at a localized area, for example, using a welding process, such as a build-up welding process or a laser welding process, with or without addition of additional material (Fig. 8).
Alternatively, theenlargement 26 may be formed by dispensingadditional material 58 onto the outer surface of theneedle 24, such as an adhesive, a resin or a metal material. Theadditional material 58 may be placed in arecess 60 which has been formed in the outer surface of theneedle 24 prior to dispensing theadditional material 58. However, formation of therecess 60 is optional.
Although only oneenlargement 26 is shown inFigs. 7 to 9, it is to be noted that more than one enlargement may be present on the outer surface of theneedle 24.

Reference numeral list

10 wing: housing
12: main body
14: distal end
16: proximal end
17: catheter
18: port
20: wing
22: chamber
24: needle
26: enlargement
28: needle safety device
30: base portion
34: first jaw
36: second jaw
38: head portion
40: head portion
42: angled end section
44: tension ring
46: link
48: annular protrusion
49: groove
50: locking shoulder
52: recess
54: locking protrusion
56: needle tip
58: additional material
60: recess

Claims

A needle safety device (28) for a medical device, the needle safety device (28) comprising:
a base portion (30) having a bore extending in an axial direction therethrough for receiving a needle (24); and
two opposing jaws (34, 36) extending from the base portion (30) generally in the axial direction and each having a head portion (38, 40) in the region of its free end, wherein at least one of the head portions (38, 40) forms a locking shoulder (50) for securing the needle safety device (28) in a housing (10) of the medical device,
characterized by
an elastic element (44) surrounding the jaws (34, 36) in a region between the base portion (30) and the head portions (38, 40), wherein the elastic element (44) and the jaws (34, 36) are configured such that the jaws (34, 36) can be spread apart against a restoring force of the elastic element (44) in order to allow the needle (24) received in the bore to extend all the way through the needle safety device (28).
A needle safety device (28) in accordance with claim 1,
characterized in that
seen in the axial direction the elastic element (44) covers a substantial part of the jaws (34, 36).
A needle safety device (28) in accordance with claim 1 or 2,
characterized in that
an axial dimension of the elastic element (44) ranges from about one fifth of the length of the jaws (34, 36) to about two thirds or three quarters of the length of the jaws (34, 36), and preferably is in the range of about one third of the length of the jaws (34, 36).
A needle safety device (28) in accordance with any one of the preceding claims,
characterized in that
the elastic element (44) is made from a material having elastic properties or an elastic material.
A needle safety device (28) in accordance with any one of the preceding claims,
characterized in that
the elastic element comprises a tension ring (44) completely surrounding the jaws (34, 36), and/or a clamp or bracket partly surrounding the jaws (34, 36).
A needle safety device (28) in accordance with any one of the preceding claims,
characterized in that
the jaws (34, 36) are connected to each other by at least one link (46) in a region between the base portion (30) and the head portions (38, 40).
A needle safety device (28) in accordance with claim 6,
characterized in that
the link (46) is arranged in the region of the elastic element (44).
A needle safety device (28) in accordance with claim 6 or 7,
characterized in that
the link (46) is provided on only one side of the jaws (34, 36).
A needle safety device (28) in accordance with claim 6 or 7,
characterized in that
first and second links are provided on opposite sides of the jaws (34, 36).
A needle safety device (28) in accordance with any one of claims 6 to 9,
characterized in that
the or each link (46) is formed to have spring-like properties such that the jaws (34, 36) can be spread apart against a restoring force of the link (46).
A needle safety device (28) in accordance with any one of claims 6 to 10,
characterized in that
the or each link (46) has a curved shape, for example an S- or Z-like shape, or a substantially straight shape.
A needle safety device (28) in accordance with any one of the preceding claims,
characterized in that
the base portion (30), the jaws (34, 36), and preferably also a link (46) connecting the jaws (34, 36), are integrally formed.
A needle safety device (28) in accordance with any one of claims 1 to 11,
characterized in that
the base portion, the jaws and/or a link (46) connecting the jaws (34, 36) each comprise a different material or combination of materials.
A needle safety device (28) in accordance with any one of the preceding claims,
characterized in that
at least one of the jaws (34) has an angled end section (42) at its free end, which extends towards the other one of the jaws (36) in a direction generally perpendicular to the axial direction.
A needle safety device (28) in accordance with claim 14,
characterized in that
the length of the angled end section (42) is selected such that the angled end section (42) is supported on the needle (24) when the needle (24) extends all the way through the needle safety device (28), thereby spreading the jaws (34, 36) apart far enough for the shoulder (50) of the head portion (38) of the jaw (34) having the angled end section (42) to engage with the housing (10) of the medical device for securing the needle safety device (28) in the housing (10).
A needle (24), in particular for a medical device such as, for example, an intravenous catheter apparatus, the needle (24) having an inner profile, a principal outer profile and a needle tip (56), the needle (24) further comprising an enlargement (26) in the region of the needle tip (56), wherein the enlargement (26) is formed from an increase of the outer profile of the needle (24) in at least one direction, whereas the inner profile remains substantially unchanged.
A needle (24) in accordance with claim 16,
characterized in that
the enlargement (26) is formed by subjecting the needle (24) to concentrated heat at a localized area using, for example, a welding process such as a laser welding process, with or without addition of additional material.
A needle (24) in accordance with claim 16 or 17,
characterized in that
the enlargement (26) is formed from additional material (58) dispensed onto the outer surface of the needle (24).
A needle (24) in accordance with claim 18,
characterized in that
the additional material (58) is selected from at least one of a plastic material, an adhesive, a resin and a metal material.
An intravenous catheter apparatus comprising:
a needle (24) in accordance with any one of claims 16 to 19;
and
a needle safety device (28), in particular in accordance with any one of claims 1 to 14, slidably arranged on the needle (24) for protecting the needle tip (56), wherein the needle safety device (28) includes a base portion (30) having a bore extending therethrough for receiving the needle (24), the bore being adapted to the principal outer profile of the needle (24).
An intravenous catheter apparatus in accordance with claim 20,
characterized in that
a, preferably annular, locking protrusion (54) for engaging with the needle safety device (28) is formed on an inner surface of a catheter hub (10) of the intravenous catheter apparatus.
An intravenous catheter apparatus in accordance with claim 21,
characterized in that
the locking protrusion (54) has a substantially rectangular profile with rounded edges or a rounded profile similar to a Gaussian curve or a semi-sinusoidal curve.